Protara Completes Enrollment for Choline Study
The clinical trial evaluates IV Choline Chloride for patients reliant on long-term parenteral nutrition support.
Updated on Oct. 15, 2026 in Healthy Food
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Protara Therapeutics has finished enrolling 24 patients for the Phase 2b dose confirmation segment of its THRIVE-3 trial. The study assesses IV Choline Chloride in patients who depend on long-term parenteral support.
Why it matters
Choline is a critical substrate for liver function, yet many patients receiving long-term parenteral support currently lack approved formulations containing the nutrient. Most of these patients suffer from some degree of liver damage.
Approximately 80 percent of adults dependent on parenteral support have a choline deficiency. Currently, about 30,000 adult patients in the United States rely on this long-term support.
The players
Protara Therapeutics
This is a clinical-stage biopharmaceutical company headquartered in New York that focuses on developing therapies for rare diseases.
The details
The Phase 2b study is an open-label trial that investigates the safety and pharmacokinetics of IV Choline Chloride across various doses. The drug has already received both Orphan Drug and Fast Track designations from the FDA.
Timeline
October 15, 2026: Protara Therapeutics announced the completion of the Phase 2b patient enrollment.
4Q 2026: Interim results from the Phase 2b cohort are expected to be reported.
Culture Shift
This development follows the regulatory framework set by the FDA Orphan Drug designation program. The trial represents a significant effort to address specific nutritional gaps in long-term care that have historically lacked specialized medical solutions.
Patients currently requiring long-term parenteral support may eventually gain access to new formulations that address chronic choline deficiency. This advancement aims to mitigate liver damage risks for the estimated 30,000 adults in the United States reliant on these treatments.
The takeaway
Patients who rely on parenteral nutrition may soon have better options for managing essential nutrient deficiencies. Ongoing research continues to highlight the importance of targeting liver health in long-term nutritional support plans.
What happens next
Protara Therapeutics is scheduled to release interim results from the Phase 2b cohort of the THRIVE-3 trial in the fourth quarter of 2026.
Further reading
Learn more about nutritional developments and industry standards in our Healthy Food section.
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Should the FDA fast-track the approval of new medical treatments for rare, life-altering conditions?
